Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Phosphorus containing other than solely as part of an...
Reexamination Certificate
2002-05-02
2004-04-20
Goldberg, Jerome D. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Phosphorus containing other than solely as part of an...
Reexamination Certificate
active
06723712
ABSTRACT:
The present invention relates to the field of the treatment of cancer and especially involves the use of antiviral agents for the treatment of cancer. The invention relates to the treatment of virus-associated cancer, or non-virus-associated cancer.
In studying various human tumor cell lines derived from virus-associated cancers, the inventors have shown that antiviral agents used in combination with other therapeutic agents, may provide a new way for the treatment of cancer, with improved sucess in controlling the development of the tumor. The inventors have also shown that said combination of an antiviral agent with another therapeutic agent may also be used advantageously in the treatment of non virus-associated cancers.
Although there has been no direct relationship established between a detected viral infection and the occurrence of cancer in human, studies have shown in the past that virus infection can be a co-factor frequently associated with carcigonenesis in infected cells and as a consequence can be linked to the development of malignant lesion and in general related with the development of cancer.
In these situations where an infection by a virus can be correlated with the development of malignancy especially in the human body, it is believed that other contributing factors may also be involved.
To date, it appears that human cancers, associated with virus infection are mainly represented by lymphomas and carcinomas. For example, infection by the Epstein-Barr virus (EBV) has been detected in nasopharyngeal carcinomas, Burkitt and other lymphomas, papillomavirus infection (HPV) has been shown to be involved in some head and neck carcinomas, and uterine cervix carcinomas, infections by Hepatitis B or C viruses have been associated with the occurrence of hepatocarcinomas.
These virus-associated cancers, where viral infection is a co-factor involved in the carcinogenesis of human cancer represent 15 to 20% of the whole number of cancers in the world (26,27).
From a general point of view, cancers, including virus-associated cancers, are treated through different ways. It is especially well-known that cancer treatment comprises surgery, radiation and chemotherapy. More recently immunotherapy has been introduced as a further available treatment regimen. It is also noted that cancers may be treated, if appropriate, with a combination of several of these available treatments. Therefore, the above-cited treatment regimens can be viewed as constituting a primary therapy or depending upon the specific cases, as an adjudant therapy.
As far as virus-associated cancers are concerned, it is noted that conventional treatments of the type of the above-cited treatment, have shown a relatively high level of failure to cure or improve the situation of the patients, especially in locally advanced disease (40-60% failure in stage III-IV nasopharyngeal carcinoma and in stage III carcinoma of the uterine cervix (27)).
Therefore, new approaches for therapeutic treatment of cancers are desirable. Such an alternative or complementary possibility of treatment of cancers is provided by the inventors through the definition of means involving the use of antiviral agents.
Interestingly, the efficiency which has been observed by the inventors on the control of tumors associated with viral infection, when using antiviral agents, has also been shown unexpectedly on non virus-associated cancers.
In a publication (1), Andrei G. et al (<<Inhibiting Effect of Cydofovir (HPMPC) on the Growth of the Human Cervical Carcinoma (SiHa) Xenografts in Athymic Nude Mice>>), have disclosed that in view of a strong association noticed between infection with specific genital viruses (HPV viruses) and the development of cervical cancer, an assay was made, to treat cell lines derived from human cervical carcinoma with HPMPC ([(S)-1-[3-hydroxy-2-(phosphonomatoxy)propyl]cytosine, Cidofovir) which is known to be an antiviral agent.
As a result of this experimental work, Andrei et al (1) have shown that cell proliferation of these cell lines was inhibited in a concentration-dependent and in a time-dependent fashion. They further report that effects of HPMPC on the growth of cervical carcinoma xenografts in athymic nude mice has been observed, allowing to conclude that animals that were injected intratumorally with HPMPC at a certain dose, have shown statistically significant reduction in tumor size compared to a placebo group or to a group of animals treated with another specific antiviral agent. They further state that, when HPMPC was administered topically or systemically, no reduction of tumor growth was observed when nontoxic concentrations of the compound were used.
Within the frame of the present invention, the inventors have observed that contrary to what has been concluded by Andrei et al in the above-cited publication, HPMPC, among other antiviral agents, can be used for the treatment of cancer and especially by using non toxic systemic concentrations. Both virus-associated cancers and non virus-associated cancers may be treated by the use of antiviral agent in appropriate conditions defined in the present invention.
The inventors provide means for the treatment of cancer, that comprise the use of antiviral agents in combination with known groups of anticancer agents, said combination enabling a synergic effect to occur between the antiviral agent and the anticancer agent. It is stated that anticancer agents implicated in the production of this synergic effect include conventional anticancer agents among those used for the anticancer conventional therapy cited hereabove.
The present invention therefore relates to a method of treatment of cancer, which comprises the steps of:
administering to a patent in need thereof an anticancer agent and
administering to said patient an antiviral agent.
Each of the features described hereafter for the definition of the type of cancer to be treated or in relation to the nature or use of the anticancer agent or of the antiviral agent is applicable for the implementation of said method of treatment.
The sequences of administration of said anticancer and said antiviral agents are defined by the skilled person.
According to the invention, the expression <<synergic effect>> signifies that the effect obtained with the combination of several agents within the scope of the invention is higher than the effect which is obtained with only one of these agents or, advantageously the effect which is obtained with the combination of the above said agents is higher than the addition of the effects obtained with each of these agents used separately.
Accordingly, the inventors have shown that antiviral agents can be used in combination with other groups of molecules, compositions, or irradiation treatments used as anti-cancer agents for the treatment of cancer, and especially for the treatment of virus-associated cancers, thereby producing an improved effect on the tumor development.
In the present invention, the expression <<antiviral agents>> relates to agents having an interaction effect and for instance an inhibitory effect on the infection of cells by a virus. Within the possible effects of said antiviral agents, one may include the capacity of the antiviral agent to inhibit the infection of the host cells by the virus and/or to inhibit the replication of the virus or the proliferation of the virus in host cells. Additionally or alternatively, the antiviral agents of the invention are agents which can have a direct effect on the infected host cells including for instance against their transformation towards a malignant state.
For the purpose of the invention, an antiviral agent which appears to produce a result in the treatment of cancer, when combined with an anticancer agent as defined hereafter, is designated as an antiviral agent.
By the expression <<anticancer agent>> is meant according to the present invention, any known agent or agent to be developed which has, in proper conditions, an activity on the formation of a malign
Abdulkarim Bassam
Bourhis Jean
Deutsch Eric
Goldberg Jerome D.
Institut Gustave Roussy
Merchant & Gould P.C.
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